510(k) · Cleared
Recalled · 2011Stereos Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biospace Med · LLZ System, Image Processing, Radiological
Cleared on Feb 4, 2011 as substantially equivalent to K080529 (Biospace Med, 2008) and 2 other predicates after a 262-day review. Its family tree reaches back 7 generations to 1991. 12 later devices descend from it. It has been recalled once.
- Decided
- Feb 4, 2011
- Review
- 262 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K904519 (1991). 14 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 6 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 5 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 4 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 3 generations backK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- 2 generations backK080529 Stereos WorkstationBiospace Med · 2008
- 1 generation backK090050 Stereos WorkstationBiospace Med · 2010
- This deviceK101398 Stereos WorkstationBiospace Med · 2011
- Descendant · cites it directly · 11 of its ownK113344 Stereos WorkstationEos Imaging · 2012
- Descendant · cites it directly · 10 of its ownK130395 Stereos WorkstationEos Imaging, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 9 of its ownK141137 Stereos WorkstationEos Imaging · 2014
- Descendant · 3 generations on · 8 of its ownK160914 sterEOS WorkstationEos Imaging, Inc. · 2016
- Descendant · 4 generations on · 7 of its ownK172346 sterEOS WorkstationEos Imaging · 2018 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K113344Stereos WorkstationEos Imaging · 2012 · cites it directly11descendants
- K130395Stereos WorkstationEos Imaging, Inc. · 2013 · cites it directly10descendants
- K141137Stereos WorkstationEos Imaging · 2014 · 2 generations on9descendants
- K160914sterEOS WorkstationEos Imaging, Inc. · 2016 · 3 generations on8descendants
- K172346sterEOS WorkstationEos Imaging · 2018 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −6 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −5 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −4 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −3 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| −2 | K080529 | Stereos Workstation | Biospace Med | 2008 | — |
| −1 | K090050 | Stereos Workstation | Biospace Med | 2010 | — |
| 0 (this device) | K101398 | Stereos Workstation | Biospace Med | 2011 | — |
| +1 | K113344 | Stereos Workstation | Eos Imaging | 2012 | — |
| +1 | K130395 | Stereos Workstation | Eos Imaging, Inc. | 2013 | 1 |
| +2 | K141137 | Stereos Workstation | Eos Imaging | 2014 | — |
| +3 | K160914 | sterEOS Workstation | Eos Imaging, Inc. | 2016 | — |
| +4 | K172346 | sterEOS Workstation | Eos Imaging | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080529 | Stereos WorkstationSummary page 1…station Classification: 21 CER 892.2050; radiological image processing system Product Code: LLZ Predicate Devices: sterEOS Workstation (K080529; K090050) Agfa Orthopedic Software for Impax Workstations (K071972) \\- 026067/0061 3203067v Devic… | 2008 |
| * | K090050 | Stereos WorkstationSummary page 1…Classification: 21 CER 892.2050; radiological image processing system Product Code: LLZ Predicate Devices: sterEOS Workstation (K080529; K090050) Agfa Orthopedic Software for Impax Workstations (K071972) \\- 026067/0061 3203067v Device Descrip… | 2010 |
| * | K071972 | Orthopedic Software for Impax WorkstationsSummary page 1…sing system Product Code: LLZ Predicate Devices: sterEOS Workstation (K080529; K090050) Agfa Orthopedic Software for Impax Workstations (K071972) \\- 026067/0061 3203067v Device Description: The sterEOS Workstation is a system for acceptance, transfer,… | 2007 |
| † | K071546 | EOS | 2007 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2011 | Not classified | Z-2692-2011 | Software design | Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K113344 (Eos Imaging, 2012) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K080529.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance, transfer. display. storage, and digital processing of 20 X-ray images of the musculoskeletal system including interactive 20 measurement tools. When using 20 X-ray images obtained with the EQS Imaging EQS System (K071546), the sterEOS Workstation provides interactive 3D…
Read the full statement (275 words)
The sterEOS Workstation is intended for use in the fields of musculoskeletal radiology and orthopedics in both pediatric and adult populations as a general PACS device for acceptance, transfer. display. storage, and digital processing of 20 X-ray images of the musculoskeletal system including interactive 20 measurement tools.
When using 20 X-ray images obtained with the EQS Imaging EQS System (K071546), the sterEOS Workstation provides interactive 3D measurement tools:
- to aid in the analysis of scoliosis and related disorders and deformities of the spine in adult patients as well as pediatric patients 7 years and older. The 3D measurement tools include interactive analysis based on a model of bone structures derived from an a priori image data set from 175 patients (91 normal patients. 47 patients with moderate idiopathic scoliosis and 37 patients with severe idiopathic scoliosis), and dry isolated vertebrae data. The model of bone structures is not intended for use in patients with a Cobb's angle > 50 degrees and is not intended for use to assess individual vertebral abnormalities.
-to aid in the analysis of lower limbs alignment and related disorders and deformities based on angle and length measurements. The 3D measurement tools include interactive analysis based either on identification of lower limb alignment landmarks or as for the spine, on a model of bone structures derived from an a priori image data set. The model of bone structures is not intended for use to assess individual bone abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 20/3D ruler is indicated for measurements in patient younger than 15 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101398: Stereos Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101398
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026